See the Glossary for more terms.
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To strengthen NIAID oversight of clinical trials and studies by requiring applicants to provide additional information to NIAID.
Incorporated into the Notice of Award, the NIAID Clinical Terms of Award specify a grantee's responsibilities and deadlines for providing documentation and approvals when starting and during a study. We may ask applicants to send us some or all of this information.
The terms apply to all NIAID-supported grants conducting human subjects research. There may be additional terms for certain countries; for example, see the NIAID Clinical Terms of Award Restriction for China.
Grant applications must follow human subjects instructions in either the SF 424 Application Guide (for an electronic application) or PHS 398 (for a paper application).
NIAID can award applications only if they provide information showing that they comply with all policies.
For grants, certain human subjects codes, 20 or 44, in IMPAC and on an application's summary statement indicate a bar to award that must be resolved before funding. Bars are placed on grants if no assurance exists or if applicants did not clearly follow the application instructions. For a list of codes, go to Human Subjects Inclusion Codes.
Find more information on human subjects requirements at NIAID Human Subjects Resources on the Research Funding Web site.
If you have questions, Contact Staff for Help.
See GMP Assignments by Geographic Region and Program Code for the appropriate GMP specialist.
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NIAID's Application portal
Grant Application, Electronic SOP
Grant Application, Paper SOP
NIAID Human Subjects Application and Grant Handbook Web page
Human Subjects Research Requirements SOP and other Human Subjects SOPs
Program Officer Checklist SOP
Required Clinical Training—Frequently Asked Questions Web page
Trans NIAID Clinical Research Toolkit
Last Updated May 07, 2013
Last Reviewed February 14, 2013